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FUNDAMENTOS TEÓRICOS

C. Antecedentes Empíricos

2.4. BASES LEGALES

industry which might influence the successful implementation

of the solution. Additionally, recommendations are provided for future research that might strengthen the understanding of the subject matter as well as insight in relevant topics which were excluded for this research project.

This chapter presents several notions and recommendations that might improve the quality of the continuation of this project. Additionally, suggestions for future research are provided that can aid in a better understanding of the total system and might prove beneficial for the company. As the solution and implementation design are both recommendations to the company, this chapter might be a bit confusing. However, this chapter addresses recommendations based on topics outside the scope of this research project.

20.1 RECOMMENDATIONS

First, the perception of value of this solution will determine the adaptation of the device by consumers. The more value it brings and the clearer it is that this device will deliver that value (it is perceived properly), the more willing a consumer will be to purchase the solution. Therefore, it should be taken into account how the value can be increased significantly without driving up the costs unnecessarily. Especially in the case of chronic diseases, this solution might offer some benefits in monitoring the disease and evaluating the effectiveness of treatment options. As mentioned, CRC is a slow-growing disease and therefore, the consumer is asked to invest in something that might become relevant in twenty years. Chronic diseases are diseases that stick for a lifetime and so, the sales pitch might be a lot clearer. One of those chronic disease could be diabetes (type 1 and 2). Diabetes is a chronic disease that must be monitored. Due to the large population of Diabetics in the Netherlands (1.2 million ) and the high costs for the healthcare system (1,6 billion ), this could be an interesting target group. Some solutions have already been developed , yet actual results must be waited for . Another type of disease could be inflammatory bowel diseases (IBD, Crohn and colitis ulcerosa fall under that typology), is also a large group of people (85.000 ). This solution could offer benefits in the case of treatment monitoring and help people with IBD to better control their disease. Additionally, when changing the focus of the solution, and thus its intended use, the efforts to comply to the regulations might decrease. With an intended use that is less-evasive and poses significant fewer risks to the users, the regulatory influence on the development and post-market surveillance decrease significantly as well. Therefore, changing the focus of the solution might prove useful in reaching market and CE conformity. Second, pivots are drastic rearrangements/changes to the current solution, implementation or business model that change the course of the company into another direction. Pivots should be employed when it is clear that the current route will not achieve the desired results or even could cause the company to fail in their quest and go bankrupt. I read about this in ‘The Lean Startup’ (Ries, 2011) and thought that it would be an interesting topic to mention and address. The company could pivot the application of the solution. Instead of human faeces, the focus could go to livestock monitoring (some even plea for the ‘connected cow’ ). Or, the company could pivot the business model and instead of at-home use go for use in the clinical context (at a GP for instance). Another way the company could pivot is not by developing the solution self, but by licensing the solution to another company and profiting from every sold product. Or instead of focussing on health and health conditions, the solution could now prevent unnecessary wear to the drainage and piping system. Thinking about possible pivots will increase the survivability of the firm in one or two ways. First, pivoting can turn an undesirable and infeasible solution into something that can be implemented. Especially in the case of firms that rely solely on one solution, this may be vital. Second, mapping possible pivots and establishing the preventive relationships for such pivots might offer new chances of applying the solution in other fields generating additional revenue streams. To be able to pivot depends on the firm’s ability to develop a generic design. The goal of a design research project is to develop a generic design: a design that “can be transferred (within a certain application domain) to contexts other than the one in which it has been made and test without losing its basic effectiveness” (Van Aken et al. 2017). For instance, when pivoting to livestock the essential functionalities of the solution remain the same: it analyses the contents of faeces and communicates them to the appropriate user. When the generalization of the design is taken into account and a generic design is strived for, the possibility to pivot becomes much more achievable and feasible. Therefore, it is wise to always consider the generic parts of the solution and how some design decisions might affect the generalizability of the solution and thus limit its survival chances.

Third, during this research project it became clear that information sharing is vital for the development of this solution. As can be read in Part I Chapter 8, the company lacks certain expertise and knowledge due to human capital related restrictions. Gaining this knowledge is only possible through discussions with experts. Therefore, sharing knowledge is insurmountable for attracting new knowledge. However, be conscious of whom the knowledge is shared with and what knowledge is shared. A basic background check can prevent many issues. As well as using an NDA with every meeting. A professional that is not in it to scam, steal, or lie will most of the times be willing to sign an NDA. Additionally, don’t be disappointed if one of those experts says ‘no’. As has been mentioned before, the medical industry is suspicious of and reluctant in adopting new tech. Last, during this research project, effort has been put in the formalizing of the company and most predominantly, in finding a suitable name. Even though I provided suggestions, the final decision was never made. Which was slightly awkward at times when applying to workshops, courses, and events: I was the graduating student for a company with no name. Additionally, from a legitimacy standpoint, it would have strengthen my exploratory claim if the company had a name and a website which could be researched by my conversation partners.

20.2 FUTURE RESEARCH

As medical devices take considerate amounts of time to be implemented completely into their appropriate context. Future events90 could have a severe impact on the development and successful of

the implementation, but the able to continue the development of the solution additional research is required.

First, the functionality and thus the desirability of this solution depends heavily on the technology and capability of the technology to analyse faeces and provide results. In the scope I mentioned, that for this assignment I am going to assume that the technology works and that the solution is able to provide the necessary results. However, in the current state of the solution this is not the complete truth. At the moment of writing, the company is able to determine some variables (as depicted in Part I chapter 1). However, the specificity and sensitivity of these measurements are still unclear. In the medical industry these must be defined. Therefore, future research could be employed to look for the appropriate technology and biomarkers that can deliver the necessary results. Organizations like MESA+ on the university are focussed on the development of methods to diversify between materials and could, therefore, from a micro-chemist perspective add to the understanding and competitive knowledge of the firm. Second, when the hardware is able to deliver the measurements, the software must be able to analyse these measurements and transform them into results that can be understood by the user. Such a software system must be able to establish a baseline measurement of all variables for a specific user and be able to distinguish results that do not fit this baseline based on statistics. Such algorithm-based software is becoming more and more embedded into the medical industry. However, the medical industry is still most predominantly reluctant to trust such systems. As these systems diagnose diseases not on a given amount of a biomarker present in the user, but rather on the similarity of physiological processes of the user compared to users with a specific disease. This is quite a big change in thinking that also this solution is subjected to. Third, what has come in many discussions with the company is the idea that the toilet in itself could also benefit from a total redesign. Developing a toilet that less dependent on massive amounts of water and perhaps cleans even more efficient could attract an additional target group. Even more so, such a redesign could remove the need to make significant changes to bathrooms, as only the toilet needs replacing, and additional grants might be applied for due to its environmental impact. Last, the last piece of future research is focused on communicating the results. The solution should be able to inform the user of its health condition in such a way that the appropriate actions can be taken. However, there is significant challenge in doing so. The results must be clear so that the user understands the importance of the results and when something is wrong, the user should take the appropriate measures. However, the solution should not scare the user or amplify unnecessary doubt in the user. So, the results must be so clear that they are understandable and that the proper action is taken, but not too direct so that the user gets scared. Decreasing the importance of the communicated results could lead to a disregard from the user about serious health issues, potentially causing disastrous results.